News

Letter Updates


Jun 5, 2025
Press Release

Chairmen Guthrie and Hudson Ask President Trump to Remove Biden-era BEAD Regulations and Expedite Funds to Deploy Rural Broadband

WASHINGTON, D.C.  – Today, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, Congressman Richard Hudson (NC-09), Chairman of the Subcommittee on Communications and Technology, sent a letter to President Donald J. Trump urging the administration to quickly remove burdensome regulations that have stopped the Broadband Equity, Access, and Deployment (BEAD) program from connecting any American to reliable broadband. KEY EXCERPT: “The Biden administration added unnecessary and burdensome requirements that made participation in the program more expensive and less attractive to broadband providers. These include labor and climate change requirements, as well as rate regulation of low-cost broadband plans that were unlawfully imposed.  “To address these issues, we introduced the Streamlining Program Efficiency and Expanding Deployment (SPEED) for BEAD Act, which outlines necessary reforms to BEAD. We appreciate that Secretary of Commerce Howard Lutnick is undertaking a review of the program and urge any reforms to be enacted as soon as possible.” BACKGROUND: On March 5, 2025,  Congressman Hudson introduced  the SPEED for BEAD Act to remove harmful regulations that have prevented the $42 billion program from laying even a single inch of fiber to support rural Americans. Also on March 5, 2025, the Committee on Energy and Commerce  held a hearing  to discuss the BEAD program titled  Fixing Biden’s Broadband Blunder. CLICK HERE to read the full letter. ###



Apr 30, 2024
Press Release

E&C Republicans Press NIH to Confirm Agency Isn’t Funding Russian Research

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight Subcommittee Republicans, wrote to National Institutes of Health (NIH) Director Monica Bertagnolli. In the letter, the Chairs ask the NIH to confirm by May 14, 2024, whether the agency has complied with White House guidance to stop funding projects led by researchers and entities in Russia.  BACKGROUND :  On June 11, 2022, the White House Office of Science and Technology Policy (OSTP) issued guidance stating such projects and programs that commenced and/or were funded prior to Russia’s further invasion of Ukraine in February 2022 may be concluded, but new projects in affected subject areas will not be initiated.   The OSTP advised applicable departments and agencies to curtail interaction with the leadership of Russian government-affiliated universities and research institutions, as well as those who have publicly expressed support for the invasion of Ukraine.  In a statement in an April 9, 2023, article in The Washington Times , the NIH’s Office of Extramural Research claimed that “NIH currently does not fund any research in Russia.”  However, the Data Abyss tracker for the OSTP Russia guidance on federal funding agencies indicates that, as of April 5, 2024, the NIH has potentially 240 instances of problematic research collaborations since June 2022 that do not comply with the guidance. CLICK HERE to read the letter.



Apr 17, 2024
Press Release

E&C Republicans Expand Investigation into Sexual Harassment at NIH to now Include Review of HHS Office of Civil Rights Compliance Role

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight Subcommittee Republicans, wrote to Department of Health and Human Services (HHS) Secretary Xavier Becerra.  The letter outlines concerns with the role HHS Office of Civil Rights (OCR) plays—or fails to play—in investigating instances of sexual harassment that occurs at research institutions which receive grants from the National Institutes of Health (NIH).  KEY EXCERPTS :  “There have been several public reports of sexual harassment occurring on NIH-funded research or NIH-supported activities over the last decade, and it raises concerns about what, if any, actions the NIH has taken to resolve these issues. The NIH’s own statistics show a significant problem with more than 300 cases related to sexual or gender harassment since 2018—with about a third of those allegations being substantiated. This also represents hundreds of men and women who may be forced to operate in a hostile or unsafe research environment.”  [...]  “According to the HHS website, OCR does investigate and resolve complaints of sexual harassment in the education and health programs of recipients of grants or other federal financial assistance from HHS—including the NIH. Moreover, HHS OCR is required to conduct periodic compliance reviews of institutional Title IX programs to ensure compliance with the law—including examining the way in which complaints are handled by the institution.”  The Chairs have requested answers to questions about HHS OCR’s role by April 30, 2024.  BACKGROUND :  Based on a recommendation from the U.S. Government Accountability Office (GAO), HHS OCR and the NIH adopted a memorandum of understanding (MOU) to facilitate communication between the two components of HHS as it relates to sexual harassment.   This MOU was intended to clarify procedures on how the enforcement arm of HHS and the grant-making arm share valuable information with one another in an effort to respond appropriately to complaints of sexual harassment and prevent federal grant money from going to those with a history of sexual misconduct.   TIMELINE OF INVESTIGATION :  August 10, 2021 : E&C Republican Leaders Question NIH’s Handling of Sexual Harassment Complaints  August 11, 2022 : E&C Republican Leaders follow up with NIH on Insufficient Response to its Letter on the NIH’s handling of Sexual Harassment  November 30, 2022 : E&C Republicans to NIH: Turn Over Previously Requested Information Ahead of New Congress  March 14, 2023 : E&C Republicans Press NIH for Information on Handling of Sexual Harassment Complaints  October 6, 2023 : E&C Republicans Signal Intent to Issue Subpoenas to Obtain Information on NIH’s Handling of Sexual Harassment if Questions Go Unanswered  January 26, 2024 : Chair Rogers notifies NIH of Imminent Subpoena  February 5, 2024 : Chair Rodgers Subpoenas NIH for Documents Related to Investigation into Sexual Harassment at NIH and NIH Grantee Institutions February 20, 2024: HHS Responds on behalf of NIH to offer a rolling in camera document review to the Committee. Documents produced in the review have been highly redacted, including the redaction of the names of individuals convicted of criminal offenses, public news articles about individuals who have been found guilty of harassment, and redaction of the names of the institutions where the abuse occurred—effectively preventing the Committee from understanding if NIH continues to fund work performed by substantiated abusers at other institutions—a practice known as “pass the harasser.”



Apr 9, 2024
Press Release

Rodgers, Capito, and Wicker Lead Amicus Brief Challenging EPA’s Overreaching So-Called ‘Good Neighbor’ Rule

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Senate Environment and Public Works Committee Ranking Member Shelley Moore Capito (R-WV), and Senator Roger Wicker (R-MS) led 26 of their colleagues in filing a bicameral amicus curiae brief in the U.S. Court of Appeals, D.C. Circuit in support of state and industry challengers to the Environmental Protection Agency’s (EPA) so-called “Good Neighbor” air rule that targets American power production and burdens states with misguided air regulations. “Acting well beyond its delegated powers under the [Clean Air Act], EPA’s Rule proposes to remake the energy sector in the affected states toward the Agency’s preferred ends. The Rule is part of the broader joint EPA-White House Strategy that oversteps the Agency’s authority by concurrently developing regulations under three separate environmental statutes. It does so not to meet any of the statutes’ individual ends but to transform the power sector. "The group of regulations—including the Rule—are designed to hurriedly rid the U.S. power sector of fossil fuels by sharply increasing the operating costs for fossil fuel-fired power plant operators, forcing the plants’ premature retirement,” the brief reads in part. BACKGROUND: The so-called “Good Neighbor” rule imposes overreaching emissions requirements on power plants, natural gas pipeline assets, and industrial plants, like steel, cement, and paper production facilities in 23 states. Other federal courts have already frozen implementation of the rule in 12 states. Despite active Supreme Court proceedings that may halt implementation of the rule nationwide, the EPA has remained committed to the illegal rule and recently proposed to add five more states to the program.  In June 2023 , Capito joined Wicker in introducing a formal challenge to the rule through a Congressional Review Act (CRA) joint resolution of disapproval.  In June 2023, Rep. Michael Burgess (R-TX) also introduced H.J.Res. 69, a formal challenge to the rule through a Congressional Review Act (CRA) joint resolution of disapproval.  In June 2022 , Ranking Member Capito sent a letter to EPA Administrator Michael Regan outlining serious concerns with the proposed “Good Neighbor Plan.”  Ranking Member Capito has criticized the EPA’s proposed “Good Neighbor Plan” during EPW hearings in March 2023 , July 2022 , and May 2022 , and in an op-ed .  In November 2023 , Chairs Rodgers, Duncan, and Johnson sent a letter to the Federal Energy Regulatory Commission expressing concerns with the impact of EPA’s suite of rules, including the “Good Neighbor” Rule (or Interstate Transport Rule), on the reliability of the nation’s electric grid. In addition to Capito and Wicker, senators who signed on to brief include, John Barrasso, (R-WY), Marsha Blackburn (R-TN), John Boozman (R-AR), Mike Braun (R-IN), John Cornyn (R-TX), Ted Cruz (R-TX), Steve Daines (R-MT), Deb Fischer (R-NE), John Hoeven (R-ND), Ron Johnson (R-WI), Cynthia M. Lummis (R-WY), Markwayne Mullin (R-OK), Pete Ricketts (R-NE), Jim Risch (R-ID), Dan Sullivan (R-AK), and John Thune (R-SD). In addition to Rodgers, House members who signed on to the brief include, Rick Allen (R-GA), Kelly Armstrong (R-ND), Troy Balderson (R-OH), Gus Bilirakis (R-FL), Larry Bucshon (R-IN), Michael Burgess (R-TX), Kat Cammack (R-FL), Earl “Buddy” Carter (R-GA), Dan Crenshaw (R-TX), John Curtis (R-UT), Jeff Duncan (R-SC), Neal Dunn (R-FL), Russ Fulcher (R-ID), Morgan Griffith (R-VA), Brett Guthrie (R-KY), Diana Harshbarger (R-TN), Richard Hudson (R-NC), John James (R-MI), John Joyce (R-PA), Bob Latta (R-OH), Debbie Lesko (R-AZ), Mariannette Miller-Meeks (R-IA), Jay Obernolte (R-CA), Gary Palmer (R-AL), Greg Pence (R-IN), August Pfluger (R-TX), Tim Walberg (R-MI), and Randy Weber (R-TX).  Full text of the brief is available here .



Feb 5, 2024
Letter

More than 150 House Republicans Demand Biden End His De Facto Ban on American LNG Exports

Washington, D.C. — More than 150 Republicans, led by Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), sent a letter to President Biden lambasting him for his de facto ban on U.S. liquefied natural gas (LNG) exports, a decision that jeopardizes the stability and affordability of natural gas domestically, hurts the American economy and jobs, undercuts our allies, and strengthens our adversaries. AS FIRST REPORTED BY FOX NEWS: More than 150 House Republicans are calling for President Biden to reverse his moratorium on liquefied natural gas (LNG) export projects, an action they argued negatively impacts the energy security of the U.S. and its allies.   The Republican lawmakers — led by House Energy and Commerce Committee Chair Cathy McMorris Rodgers, R-Wash., and joined by House Speaker Mike Johnson, R-La., Majority Leader Steve Scalise, R-La., and Conference Chair Elise Stefanik, R-N.Y. — penned a letter to Biden on Sunday evening, demanding his administration "expeditiously approve all pending applications to increase the global supply of natural gas."   KEY LETTER QUOTE: We write regarding the announcement that the Department of Energy (DOE) will stop issuing indefinitely permits to export liquefied natural gas (LNG) while your administration conducts an additional “public interest” review, including environmental, economic, and environmental justice criteria. This is economically and strategically dangerous and unnecessary. Under both Democratic and Republican administrations, DOE has consistently found that U.S. LNG exports serve the “public interest” because they contribute positive economic benefits and strengthen energy security for the American people, and also have the potential to reduce global greenhouse gas (GHG) emissions. BACKGROUND: On January 26, President Biden froze the approval process for new U.S. LNG export sites, prioritizing the wishes of radical activists over U.S. energy security and the security of our allies. Studies show that LNG exports could add upwards of $73 billion to the U.S. economy by 2040, create upwards of 453,000 American jobs, and increase U.S. held purchasing power by $30 billion.   Over the past seven years, the U.S. has increased its LNG export capacity from zero to 11.6 billion cubic feet per day. During the same period, the spot price of U.S. natural gas has remained relatively stable and affordable.  These actions will weaken global energy security, halt investment in American energy, and jeopardize U.S. energy leadership.  CLICK HERE to read the full letter.  CLICK HERE to read more on how President Biden’s efforts jeopardize American jobs, energy prices, the economy, and the security of our allies. 



Jan 3, 2024
Press Release

E&C Republicans Launch Investigation into Internal Scientific Disagreements at FDA

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight subcommittee Republicans, wrote to Food and Drug Administration (FDA) Commissioner Robert Califf regarding how the agency handles internal scientific disagreements. Of particular concern to the Committee is whether FDA scientists face possible retaliation for expressing differing scientific views. In the letter, the Chairs note they are prepared to pursue compulsory measures should the FDA fail to respond in a timely, good-faith manner. KEY LETTER EXCERPTS : “ [I]n August 2021, the FDA announced two top vaccine regulators were leaving the agency. One reason cited for the departures was that they were upset about the Biden administration’s announcement that adults should get a coronavirus booster vaccination eight months after they received their second shot. Neither reportedly believed there was enough data to justify offering booster shots yet, and both viewed the announcement by President Biden as pressure on the FDA to authorize the shots quickly. It is unknown whether the FDA dispute resolution process was used, and if not, why not. We are concerned that the FDA may have retaliated against career FDA regulators who were viewed as insufficiently cooperative with the Biden administration’s agenda. ” […] “Given the renewed interest in updated scientific integrity policy, the Committee seeks information on the adequacy of the FDA’s existing policies for handling scientific disagreements, and whether FDA leadership has taken retaliatory actions against dissenting FDA officials." BACKGROUND : A September 2023 Government Accountability Office (GAO) report highlighted the Department of Health and Human Services’ (HHS) interest in developing processes for differing scientific opinions. The GAO also noted that the FDA has existing dispute resolution policies and may continue to use them when the updated scientific integrity policy is finalized. In addition, the GAO has issued two other recent reports that are pertinent to the FDA’s handling of internal scientific disagreements. In June 2012, the HHS Office of Inspector General (OIG) issued a study, Scientific Disagreements Regarding Medical Device Regulatory Decisions . The OIG found that accountability for the completeness of administrative files related to scientific disagreements was unclear as Not all Center for Devices and Radiological Health (CDRH) managers and reviewers received training on the new procedures CDRH faced broader challenges in identifying and resolving scientific disagreements because of uncertainty about regulatory definitions and processes and staff perceptions about expressing differences of opinion Further, the OIG recommended that the FDA: (1) define more clearly its requirements for documenting and resolving scientific disagreements (2) train all reviewers and managers on the new policies and procedures for resolving scientific disagreements (3) more clearly assign accountability for the contents of the administrative files of all submissions The FDA concurred with all three recommendations. The Chairs requested a response with the following information by January 17, 2024:  Copies of the administrative files related to all internal scientific disagreements at the FDA since January 1, 2018, documenting whether and/or how the resolution was reached and the basis, including any joint memoranda. All documents since January 1, 2018, related to the Office of Chief Scientist handling of appeals of internal scientific disagreements at the FDA. All documents related to the scientific disagreement within the FDA over coronavirus booster vaccination during summer 2021. If the internal process was not used, please provide all documents related to any changes in decision-making authority on the coronavirus booster vaccination during summer 2021 (e.g., authority removed from the director and deputy director of the Center for Biologics Evaluation and Research (CBER) vaccines office and reassigned to the CBER director). All documents since January 1, 2018, related to all instances where decision-making authority was removed from FDA officials involved in regulatory decisions. CLICK HERE to view the full letter.



Dec 14, 2023
Press Release

E&C Republicans Send Follow Up Letter to FDA Regarding Foreign Drug Inspection Program

Chairs signal intent to subpoena if FDA continues stonewalling crucial request Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffth (R-VA), on behalf of the Health and Oversight Republicans, sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf. The letter follows up on a previous request for information related to the agency’s foreign drug inspection program and comes amid the Committee’s work to address drug shortages . To date, the FDA has not provided any response to the Committee.  KEY LETTER EXCERPT :  “The U.S. cannot afford additional disruptions to the drug supply chain that reduce the availability of essential medications and force doctors and patients to make difficult treatment decisions. Members of this Committee have repeatedly expressed concern regarding the effectiveness of the FDA’s foreign drug inspection program, including at two separate hearings this Congress before the Subcommittee on Oversight and Investigations and the Subcommittee on Health. Addressing drug shortages remains a top priority for the Committee.”  BACKGROUND :  Since the Committee’s July letter to the FDA, there have been additional drug recalls from Indian manufacturers and plant closures in the United States.   In August, Indian drug manufacturers, Alembic and Aurobindo Pharma, issued voluntary drug recalls citing quality and manufacturing deficiencies, respectively.   Alembic recalled over 80,000 bottles of tobramycin, used to treat bacterial eye infections, due to “failed impurities/degradation specifications.”  Aurobindo recalled rufinamide tablets used to treat seizure disorders.  Both companies have a history of drug recalls and quality control failures.   Last year, the FDA issued Alembic a Form 483, which cited its manufacturing plant in Panelav, Gujarat with four observations following a 10-day inspection.  It has come to light that the FDA ended its unannounced foreign inspection program out because the agency believed it was an obstacle to deeper collaboration with India.   The reporting also alleges that the FDA undermined a Department of Defense initiative to independently test the quality of imported drugs used by the military out of fear that it would undermine the FDA’s credibility.   In addition, a newly published study has confirmed that FDA foreign inspections in 2022 were down 79 percent compared to 2019 while at the same time the number of “citations rose dramatically, despite all establishments being given advance notice of inspections.”   ADDITIONAL BACKGROUND :  Domestic production of vital medicines continues to be under stress.   In early August, Pfizer announced it would limit the distribution of injectable drugs manufactured at its North Carolina plant after the facility suffered damage in the aftermath of a tornado.   In September, autoinjector maker Aktiv Pharma Group (“AktiVax, Inc.”), which produces autoinjectors to treat life threating conditions, announced the closure of three manufacturing facilities.   Just last year, the company w as awarded over $45 million to supply a nerve agent antidote to the Strategic National Stockpile. While shortages of cancer drugs appear to have eased slightly in recent months, demand continues to outstrip supply .  The Chairs are prepared to issue a subpoena if the FDA does not produce the requested documents January 5, 2024. CLICK HERE to read the letter.



Nov 29, 2023
Health

E&C Republicans Demand Transparency from CDC Regarding Uptick in Suspicious Respiratory Virus in China

Letter comes ahead of Director Cohen’s testimony before Oversight Subcommittee Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight subcommittee Republicans, today wrote to Centers for Disease Control and Prevention Director Mandy Cohen, who is slated to testify before the Oversight Subcommittee tommorrow, November 30. KEY LETTER EXCERPTS :  “ The Centers for Disease Control and Protection’s (CDC) failure to communicate accurate information in real-time during the COVID-19 pandemic has undermined public trust in the agency. If the CDC is to regain credibility with the American people, it must be transparent and forthcoming with the information it has on public health threats facing our nation. “It is widely known that China thwarted international efforts, including efforts by the CDC, to respond to the burgeoning COVID-19 crisis as it began to unfold in China. Even the World Health Organization (WHO), which has long been criticized for being overly accommodating to the Chinese Communist Party (CCP), has called China’s decision to withhold information from the early days of the COVID-19 pandemic ‘simply inexcusable.’ “The WHO has now called on China to provide epidemiologic and clinical information, as well as laboratory results, on the reported pneumonia clusters among children, in addition to information on recent trends of known pathogen circulation. It would be an abdication of the CDC’s duty to the American people if it allows China to repeat its misdeeds from the COVID-19 pandemic. The American people should not have to rely on the unaccountable and untrustworthy WHO to communicate information about Chinese public health threats. Further, we cannot allow the CCP to block the CDC from accessing the information it needs to protect Americans and assist in appropriate public health response efforts.”  The Chairs requested bi-weekly briefings and answers to the following questions by December 13, 2023:  Has the CDC engaged with or interacted with its Chinese counterparts with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia?  If yes, when did the CDC and its Chinese counterparts first interact with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia? Who initiated this interaction?  At any point did the CDC’s Chinese counterparts withhold information or fail to respond to the CDC in a timely manner with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia? Please detail each instance and the topic of inquiry that prompted such failure to respond in a timely manner. What specific information, if any, has the CDC sought from China with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia? What specific information, if any, has the CDC received from China with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia? Please detail the length of time it took China to respond to each inquiry for information. What specific response efforts, if any, has the CDC offered to take part in with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia?  What specific response efforts, if any, has the CDC taken part in, is actively taking part in, or plans to take part in with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia?  Has specific information on the outbreak been communicated to relevant federal agencies and/or key stakeholders, including:  The Administration for Strategic Preparedness and Response (ASPR);  The U.S. Food and Drug Administration (FDA);  The National Institutes of Health (NIH); The Surgeon General; Department of Defense; Other Federal entities; and/or  State and local public health officials CLICK HERE to read the letter.



Nov 9, 2023
Press Release

E&C Republicans to FDA: Turn Over Documents on FDA-Funded Risky Research or Face Subpoena

Washington, D.C. — In a final warning to the Food and Drug Administration (FDA), House Energy and Commerce Committee Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight Subcommittee Republicans, threatened to issue a subpoena for documents related to risky research conducted at FDA facilities. The letter follows two previous requests for documents regarding experiments involving virus manipulation, which the FDA has acknowledged occurred in some of its research studies.   November 9, 2023  The Honorable Robert M. Califf, M.D., MACC  Commissioner  U.S. Food and Drug Administration  10903 New Hampshire Avenue  Silver Spring, MD 20903  Dr. Califf,  The Committee sent the U.S. Food and Drug Administration (FDA) a letter on March 27, 2023, regarding FDA-funded research that may pose significant biosafety or biosecurity risks. Following the FDA’s insufficient response on May 26, 2023, we sent a follow up letter on June 29, 2023. To date, the FDA has only produced 29 pages of the charter documents for the Institutional Biosafety (IBC) and the Dual Use Research of Concern (DURC) review panel, which were not sent until October 20, 2023. Having not received an adequate response to our follow-up letter, we are sending a formal document request to obtain information needed for our oversight that we requested in the June 29 letter.  Pursuant to Rules X and XI of the U.S. House of Representatives, please provide the following by November 28, 2023:  All coronavirus research studies referenced in the January 31, 2023, email. All studies that have undergone Institutional Biosafety Committee (IBC) review at the FDA since October 1, 2013, and all documents related to the IBC reviews of these studies.   All studies that have undergone Dual Use Research of Concern (DURC) review at the FDA since October 1, 2013, and all documents related to the DURC reviews of these studies.   All policies and/or procedures related to the IBC and DURC processes.   In the May 26, 2023, response letter, the FDA stated that the Center for Biologic Evaluation and Research (CBER) research studies involving coronaviruses and viral manipulation of SARS-CoV-2 “underwent applicable Institutional Biosafety Committee (IBC) review, including attestation by the principal investigator (PIs) regarding Dual Use Research of Concern (DURC) screening.” The FDA added “[n]one of these studies rose to the level of DURC review.” Please provide all documents related to these statements.  In the May 26, 2023, response letter, the FDA stated that a Center for Drug Evaluation and Research (CDER) laboratory performs studies to monitor and evaluate seasonal influenza virus resistance to clinically relevant antivirals. Please provide all documents related to these studies, including the IBC and DURC applications and approvals.   In the May 26, 2023, response letter, FDA stated that FDA requires “any research associated with hazardous biological agents and toxins (HBATs) be subject to full IBC review.” Please provide all documents since October 1, 2013, associated with HBATs, including documents related to full IBC review.  In the May 26, 2023, response letter, the FDA stated that “[s]ince September 2015, and prior to the establishment of the DRP, the FDA’s IBC application process required the attestation of all PIs concerning the nature of their work as it related to DURC policies.” Please provide a copy of the IBC application with the attestation requirement, and all documents related to the establishment of the attestation requirement.  All documents related to all extramural research that have gone through the FDA IBC and/or DURC review since September 1, 2015.    Thus, to carry out our Constitutional responsibilities of oversight, if the FDA does not produce the requested documents by November 23, 2023, it will be necessary to issue a subpoena for documents since the FDA has delayed its response and the committee has a right to obtain these materials to aid in its legislative activities and to ensure that the Executive Branch is complying with the law.  If you have any questions, please contact the Majority Committee staff at (202) 225-3641. Thank you for your attention to this request.  CLICK HERE to view the letter.  CLICK HERE to read the March 27, 2023. letter.  CLICK HERE to read the June 29, 2023, letter.